Senior Pharmacovigilance Specialist
- Beykoz, İstanbul
- Sürekli
- Tam zamanlı
- Bachelor's degree in Pharmacy (minimum BSc),
- Minimum 5 years of experience in pharmacovigilance practices,
- Excellent command of English, both written and spoken,
- Proficient in MS Office programs,
- Able to adapt to a hybrid working model,
- No travel restrictions.
- Ensure the effective operation and integration of global and local pharmacovigilance systems,
- Coordinate with internal departments and PV service providers; manage audits when needed,
- Prepare and maintain essential regulatory documents such as PSMF and PSURs,
- Lead pharmacovigilance training programs for employees and partners,
- Manage safety-related aspects of customer complaints and ensure timely authority reporting,
- Monitor regulatory changes (EMA, FDA, HMA, TITCK) and implement necessary updates,
- Oversee SmPC/PL management and updates via official sources,
- Handle Safety Data Exchange Agreements (SDEAs) with all relevant stakeholders,
- Ensure timely, compliant communication with health authorities,
- Drive GVP implementation and awareness across the organization.